Class 2 Device Recall BD Vacutainer Push Button Blood Collection Set

• Date Initiated by Firm: August 08, 2016
• Create Date: September 01, 2016
• Recall Status: Terminated on November 20, 2017
• Recall Number: Z-2710-2016
• Recall Event ID: 74909
• 510(K)Number: K030573
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
• Code Information: Lot number: 5355531, 5355533, 5356681, 5356682, 6006629, 6006630, 6006631, 6006633, 6006634 and 6006650.
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Mr. Matthew Kelleher; 201-847-6910
• Manufacturer Reason for Recall: Becton Dickinson is recalling various lot numbers of BD Vacutainer Push Button Blood Collection Set because of reports that specific lots exhibit separation of fron and rear barrels upon activation of the safety feature, which retracts the needle.
• FDA Determined Cause: Under Investigation by firm
• Action: BD notified their customers via e-mail and sent an "Urgent Product Recall Letter" and a Recall Response Form dated August 8, 2016 via UPS.
• Quantity in Commerce: 1,788,150 units
• Distribution: US and International
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JKA